Safety of Sildenafil in Premature Infants



Status:Recruiting
Conditions:Bronchitis
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:Any
Updated:1/17/2019
Start Date:April 2, 2018
End Date:August 2019
Contact:Matthew M Laughon, MD, MPH
Email:matt_laughon@med.unc.edu
Phone:984-974-7851

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Safety of Sildenafil in Premature Infants at Risk of Bronchopulmonary Dysplasia

Describe the safety of sildenafil in premature infants at risk of bronchopulmonary dysplasia
and determine preliminary effectiveness and pharmacokinetics (PK) of sildenafil. Funding
Source - FDA OOPD.

This will be a multi-center, randomized, placebo-controlled, sequential dose escalating,
double masked, safety data study of sildenafil in premature infants.

This is a Phase II study design, premature infants (inpatient in neonatal intensive care
units) will be randomized in a dose escalating approach 3:1 (sildenafil: placebo) into 3
cohorts with escalating doses of sildenafil. There will be 40 randomized and dosed
participants in each cohort for a total of up to 120 participants. Cohort 1 sildenafil dose
will be 0.125 mg/kg q 8 hours IV or 0.25 mg/kg q 8 hours enteral. Cohort 2 sildenafil dose
will be 0.5 mg/kg q 8 hours IV or 1.0 mg/kg q 8 hours enteral. Cohort 3 sildenafil dose will
be 1 mg/kg q 8 hours IV or 2 mg/kg q 8 hours enteral.

Inclusion Criteria:

- Receiving positive airway pressure (nasal continuous airway pressure, nasal
intermittent positive pressure ventilation, or nasal cannula flow > 1LPM) or
mechanical ventilation (high frequency or conventional)

- <29 weeks gestational age at birth

- 7-28 (inclusive) days postnatal age at time of randomization

Exclusion Criteria:

- Currently receiving vasopressors

- Currently receiving inhaled nitric oxide

- Baseline mean arterial pressure < gestational age (in weeks) plus postnatal age (in
weeks) within 2 hours of sildenafil administration

- Known allergy to sildenafil

- Known sickle cell disease

- AST > 225 U/L < 72 hours prior to randomization

- ALT > 150 U/L < 72 hours prior to randomization
We found this trial at
11
sites
New Orleans, Louisiana 70115
Principal Investigator: Amanda England, MD
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Principal Investigator: Brenda Poindexter, MD
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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529 West Markham Street
Little Rock, Arkansas 72205
(501) 686-7000
Principal Investigator: Sherry Courtney, MD
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
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Brooklyn, New York 11203
Principal Investigator: Gratias Mundakel, MD
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Brooklyn, NY
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Indianapolis, Indiana 46202
Principal Investigator: Gregory Sokol, MD
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Indianapolis, IN
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800 Hope Place
Las Vegas, Nevada 89106
Principal Investigator: Alaa Eldemerdash, MD
Phone: 702-207-8345
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New Hyde Park, New York 11040
Principal Investigator: Mohamed N Ahmed, MD
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1100 N. Lindsay
Oklahoma City, Oklahoma 73104
(405) 271-4000
Principal Investigator: Kimberly Ernst, MD
University of Oklahoma The OU Health Sciences Center is composed of seven health-related colleges located...
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Raleigh, North Carolina 27610
Principal Investigator: Stephen Kicklighter, MD
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Raleigh, NC
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601 Elmwood Avenue
Rochester, New York 14642
Principal Investigator: Gloria Pryhuber, MD
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Rochester, NY
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550 N Hillside St
Wichita, Kansas 67214
(316) 962-2000
Principal Investigator: Barry Bloom, MD
Wesley Medical Center Welcome to one of the most experienced and comprehensive medical centers in...
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